Senior Quality Assurance Manager

Sr. Manager, Quality Assurance Operations

Watertown, Massachusetts

Biologics, Drug Substance | CDMO

Metric Bio are partnering with a global CDMO on a search for a Manager, Quality Assurance Operations to lead late-phase and commercial QA activities in a GMP-regulated environment.

This role plays a critical part in strengthening quality oversight across process and material lifecycles while building scalable quality systems to support continued growth.

Key Responsibilities

• Lead and develop the QA Operations team (hiring, coaching, performance management)
• Ensure site-wide adherence to cGMP requirements
• Oversee incoming material release, batch record review, lot disposition, and validation protocol/report review
• Manage deviations, CAPAs, complaints, and investigations, ensuring timely closure
• Drive quality metrics reporting and continuous improvement initiatives
• Provide QA oversight for clinical and commercial programs, including tech transfer and stability
• Support internal audits, customer audits, and regulatory inspections
• Partner with site leadership and global Quality teams to align systems with regulatory and corporate expectations
• Contribute to risk management activities and escalate quality issues as needed
• Support Quality Management Reviews

Requirements

• BSc in a scientific or life sciences-related discipline
• 7+ years of Quality Assurance experience in a GMP-regulated environment
• Minimum of 3 years of people leadership experience
• Strong knowledge of FDA, ICH, and EU GxP regulations
• Experience managing deviations, CAPAs, complaints, and investigations
• Experience with root cause analysis and internal audit systems
• Experience working within Risk Management and New Product Development
• Experience supporting internal, customer, and regulatory audits
• CDMO/CMO experience preferred
• Familiarity with eQMS and document management systems
• Proficiency with Microsoft Office Suite